REGURIN XL 60MG CAPSULE

Transcript

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Regurin® XL 60mg Capsule
(trospium chloride)

Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if
their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

In this leaflet:
1. What Regurin XL is and what it is used for
2. Before you take Regurin XL
3. How to take Regurin XL
4. Possible side effects
5. How to store Regurin XL
6. Further information
1. WHAT REGURIN XL IS AND WHAT IT IS
USED FOR
Regurin XL is a medicine used for the relaxation
of the muscles of the bladder. It is used for the
treatment of symptoms associated with
involuntary loss of urine (wetting) and/or
increased frequency of urination and/ or urgency
of urination in patients with an overactive
bladder.
2. BEFORE YOU TAKE REGURIN XL
Do not take Regurin XL
- If you have ever had an allergic reaction to
trospium chloride or any of the other ingredients
of Regurin XL (An allergic reaction can be a rash,
itchiness or shortness of breath.). For the list of
ingredients in Regurin XL, please see section 6.
- If you suffer from any of the following:
• urinary retention, i.e. blockage of the urinary
tract,
• the eye condition narrow-angle glaucoma,
• abnormal/faster than normal heart beats,
• myasthenia gravis (a disorder that causes
muscle fatigue),
• a severe gastro-intestinal condition, such as
toxic megacolon,
• problems with your kidneys,
• severe problems with your liver.
Take special care with Regurin XL
If you suffer from any of the following:
• any type of stomach or bowel obstruction,
• difficulties in passing urine and/or a poor
stream of urine (male prostate disorders),
• neuropathy, i.e. nerve damage,
• a hernia of the diaphragm with inflammation of
the oesophagus due to reflux of gastric acid
(hiatus hernia associated with reflux
oesophagitis). This is usually associated with
heartburn which worsens on bending or lying
down,
• an overactive thyroid,
• any heart conditions, such as coronary artery
disease or congestive heart failure,
• any liver problems.
Talk to your doctor before starting your
treatment with Regurin XL if you think any of
these might apply to you.
Patients with liver disorders
You should talk to your doctor if you have a liver
disorder. Patients with severe liver disorders
should not take this medicine.
Patients with kidney disorders
You should talk to your doctor if you have a
kidney disorder. Patients with kidney disorders
should not take this medicine.
Children under the age of 18 years
Do NOT give Regurin XL to children under 18
years of age.
Taking other medicines
Please tell your doctor or pharmacist if you are
taking or have recently taken any other
medicines, including medicines obtained without
a prescription.
Inform your doctor in particular if you are taking
any of the following medicines:
• certain antidepressants e.g. amitryptiline or
imipramine
• some medicines for the treatment of asthma
that may accelerate the heart rate (e.g.
salbutamol)
• other medicines with anticholinergic action
(such as those used to treat Parkinson’s
disease, asthma and stomach cramps)
- metoclopramide – medicine used for nausea
and vomiting
- medicines containing guar, colestipol or
colestyramine.
Please note that this information may also apply
to medicines that you have used recently.

Pregnancy and breast-feeding
Since there is no experience with trospium
chloride during pregnancy and breast feeding,
Regurin XL should be taken during pregnancy
and breast-feeding only if your doctor considers
it absolutely necessary.
Driving and using machines
Regurin XL can cause blurred vision. If you
experience this, do not drive or use any tools or
machines.
Important information about some of the
ingredients of Regurin XL
This medicine contains sucrose. If you know that
you have an intolerance to certain sugars,
please take Regurin XL only after consultation
with your doctor.
3. HOW TO TAKE REGURIN XL
Please always take Regurin XL as your doctor
has told you. You should check with your doctor
or pharmacist if you are not sure.
Usual dose unless otherwise prescribed by
your Doctor
Unless otherwise prescribed by your doctor, the
usual daily dose is one Regurin XL prolongedrelease capsule.
Method of administration
Swallow one prolonged-release capsule whole
with a glass of water. Take the capsule at least
one hour before a meal on an empty stomach.
Duration of administration
Your doctor will determine the duration of
treatment.
The need for continued treatment should be
checked at regular intervals of 3 – 6 months.
Patients with a kidney disorder should consult
their doctor and not take this medicine.
Patients with a liver disorder should consult their
doctor before taking this medicine.
If you take more Regurin XL than you should
If you have taken too much Regurin XL you
should contact your doctor or go to the nearest
hospital casualty department immediately.
If you forget to take Regurin XL
If you forget to take a capsule, take your capsule
as soon as you remember, but do not take more
than one capsule in one day. Do not take a
double dose to make up for a forgotten capsule.
If you stop taking Regurin XL
Your symptoms may return if you stop taking
Regurin XL before recommended by your doctor.
Therefore, you should take Regurin XL for as
long as prescribed by your doctor. Please
consult your doctor if you wish to stop treatment.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Regurin XL can cause side
effects, although not everybody gets them.
The following “very rare” side effects below are
important and will require immediate action if
you experience them. You should stop taking
Regurin XL and see your doctor immediately if
the following symptoms occur:
• swelling of the face, tongue and windpipe
which can cause great difficulty in breathing
• a sudden allergic reaction with shortness of
breath, rash, wheezing and drop of blood
pressure.

What Regurin XL looks like and contents of
the pack
Regurin XL 60mg capsule, hard has an opaque
orange cap and an opaque white body imprinted
with SAN 60 and contain white to off-white
pellets.
Regurin XL is available in packs containing
30, 100 prolonged-release capsules.
Manufactured by:
MADAUS GmbH,
51101 Cologne,
Germany.

The following side effects have been reported
for Regurin XL prolonged-release capsules, hard
in clinical trials:
Very common side effects, affects more than
1 user in 10
• dryness of the mouth.

Uncommon side effects, affects 1 to 10 users
in 1, 000
• flatulence
Rare side effects, affects 1 to 10 users in
10,000
• difficulty emptying the bladder, urinary
retention,
• fast heart rate, palpitations,
• difficulty seeing objects close-up,
• rash,
• general feeling of weakness.
Very rare side effects, affects less than 1
user in 10,000
• urinary tract infection,
• headache.
The following side effects have also been
reported for trospium (trospium is the active
ingredient of Regurin XL; it is not known if these
side effects will also occur with the capsules that
you have been prescribed):
Difficulty in breathing, diarrhoea, chest pain,
slight to moderate increase of certain liver
values (serum transaminases), fast irregular
heartbeat, joint or muscle pains, dizziness.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide
more information on the safety of this medicine.
5. HOW TO STORE REGURIN XL
Keep out of the sight and reach of children.
Do not use Regurin XL after the expiry date
which is stated on the blister and the container
after EXP. The expiry date refers to the last day
of that month.
This medicinal product does not require any
special storage conditions.
Do not use Regurin XL if you notice that the
package has been damaged or shows signs of
tampering.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.
6. FURTHER INFORMATION
What Regurin XL contains
The active substance is: Trospium chloride.
Each prolonged-release capsule contains 60 mg
trospium chloride.
The other ingredients are:
Capsule contents: sucrose, corn starch, methyl
acrylate-methyl methacrylate-methacrylic acidcopolymer, ammonium hydroxide, medium chain
triglycerides, oleic acid, ethylcellulose, titanium
dioxide (E 171), hypromellose, macrogol 400,
polysorbate 80, triethyl citrate, talc, sodium
dodecyl sulphate
Capsule shell: gelatin, titanium dioxide (E 171),
Iron (III) - hydroxide oxides (E172), Iron (III)
oxide printing ink (shellac, iron II/III oxide E172,
propylene glycol)

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.